Vibe SF Self-Fitting Hearing Aid— 510(k) K220403

Substantially Equivalent

Wsaud A/S

FDA 510(k) clearance K220403 for Vibe SF Self-Fitting Hearing Aid, Substantially Equivalent on 2022-08-12. Applicant: Wsaud A/S. Device class: 2.

Clearance details

Applicant: Wsaud A/S
Product code: Code QDD
Device class: Class 2
Regulation: 21 CFR 874.3325
Advisory panel: Ear, Nose, Throat
Date received: 2022-02-11
Decision date: 2022-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lynge, DK

Download summary PDF View on FDA.gov ↗

Recent devices under product code QDD

K223911 — Lumen 155-SF2023-10-17
K220303 — MDHearingAid app, MDHearingAid Smart hearing aids2022-08-04
K213424 — Jabra Enhance Plus2022-01-19
K212609 — BHA100 Series Braun Clear Hearing Aid2022-01-05
K211008 — Bose SoundControl Hearing Aids2021-05-05

More clearances from Wsaud A/S

K233464 — WSA Self-Fitting Hearing Aid Gen 22024-02-09

Data sourced from openFDA. This site is unofficial and independent of the FDA.